What assessments and monitoring are required with KISQALI?
Treatment with KISQALI, in combination with an aromatase inhibitor (AI) or fulvestrant, for the treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) requires standard assessments to help patients start and stay on therapy, including complete blood count (CBC), liver function tests (LFTs), electrolytes, and 2 electrocardiograms (ECGs). Additional assessments may be required as clinically indicated. Review information about these standard assessments below.1
SCHEDULE
Complete most of the scheduled assessments for KISQALI within the first 2 months of therapy—with none beyond Cycle 6
Assessment1 | Baseline | Cycle 1 | Cycle 2 | Cycle 3-6 | |
Day 14 | Day 1 | Day 14 | Day 1 | ||
CBC and LFT |  | | | | |
Electrolytes | |  | | | |
ECG | | | | | |
Monitoring requirements based on a 28-day treatment cycle.
Routine monitoring for lab abnormalities1
Blood tests are performed at baseline, on Day 14 of Cycle 1, on Days 1 and 14 of Cycle 2, on Day 1 of Cycles 3 through 6, and as clinically indicated
For LFTs, if grade ≥2 abnormalities are noted, more frequent monitoring is recommended
Correct any electrolyte abnormalities prior to treatment
Additional monitoring may be required as clinically indicated
2 required ECG assessments completed within the first 2 weeks of treatment1
ECGs are performed at baseline, on Day 14 of Cycle 1, and as clinically indicated
KISQALI should only be initiated in patients with QTcF <450 ms
In case of QTcF prolongation during therapy, more frequent assessments are recommended
Additional monitoring may be required as clinically indicated
CBC, complete blood count; ECG, electrocardiogram; LFT, liver function test; QTcF, QT interval corrected by Fridericia's formula.
The majority of adverse reactions with KISQALI were manageable and reversible
Review the dose adjustment guidance and safety information for KISQALI
QT PROLONGATION
Low incidence of QT prolongation across KISQALI trials
In a pooled analysis across 3 phase III trials of 1054 premenopausal and postmenopausal patients treated with KISQALI + an AI or fulvestrant1:
There were no reported cases of torsades de pointes.1
KISQALI has been shown to prolong the QT interval in a concentration-dependent manner
In MONALEESA-2, there was 1 (0.3%) sudden death in a patient with grade 3 hypokalemia and grade 2 QT prolongation
Based on the observed QT prolongation during treatment, KISQALI may require dose interruption, reduction, or discontinuation
In case of QTcF prolongation during therapy, more frequent assessments are recommended
In the subgroup of patients who received tamoxifen, an increased risk for QT prolongation was observed.
KISQALI is not indicated for concomitant use with tamoxifen.
Most cases of QT prolongation in the pooled analysis were moderate in nature
Clinical trial | >500 ms postbaseline | >60 ms increase |
MONALEESA-2: | <1% | 3% |
MONALEESA-3: | 2% | 7% |
MONALEESA-7: | NR | 7% |
A brochure addressing perceptions about QT prolongation with KISQALI
1L, first line; 2L, second line; AI, aromatase inhibitor; NR, not reported.
ECG MONITORING
ECG device monitoring program
A flexible program designed to meet the needs of you and your patients’ treatment plans.
The KISQALI ECG Device Monitoring Program can provide you or your patients with a KardiaMobile 6L ECG device so ECG assessments can be completed in seconds in your office or at home.
In-Office option for eligible practices to receive a fast and simple-to-use ECG monitoring device that will allow them to easily monitor their patients taking or being evaluated for KISQALI
Direct-to-Patient option designed so patients can complete their ECG without a trip to the office
There is no direct cost to you or your patients for participating in this program
Actual ECG reading takes seconds and fits into any office workflow. QTcF results from the ECG device are available instantaneously, with the option for a board-certified cardiologist overread
Limitations apply. KISQALI ECG Device Monitoring Program is only permitted to be used for monitoring or evaluating a patient for the current or potential administration of ribociclib. The equipment or services are not permitted to be used for any purpose outside of the scope of the program. You must not bill any entity or person for any equipment or services relating to the provision or interpretation of the ECG. In the event that you fail to abide by the rules of the KISQALI ECG Device Monitoring Program, your participation in the program may be terminated or modified at any time without prior notice, and you may be subject to additional remedies. Additional terms and conditions apply.
Sunshine Act costs may apply.
For additional information, please contact your Novartis Oncology Specialist.
Learn more about the AliveCor® KardiaMobile 6L ECG device and how to use it
In-Office ECG monitoring with AliveCor® KardiaMobile 6L
KISQALI Assessments Checklist
KISQALI Treatment Guide
KISQALI ECG Program Brochure
KISQALI Financial Assistance Brochure
HER2-, human epidermal growth factor receptor 2-negative; HR+, hormone receptor-positive.